Evaluation of a novel method that measures beta-cell function by dried blood spots in children and adolescents with a recent diagnosis of type 1 diabetes (C-pepT1D)

Background
The main purpose of this study is to evaluate a new method of measuring a protein called C-peptide by means of taking finger drop samples of blood from newly diagnosed patients with type 1 diabetes. At diagnosis, there are usually a small number of beta cells left in the pancreas which still produce insulin. We call this beta cell function. We can tell how much beta cell function you have left by measuring C-peptide which is a protein that is made when insulin is produced. Measuring C-peptide from your blood can tell us how much insulin they you are making yourself. Most people with diabetes eventually lose the ability to produce insulin themselves. However, we know that the longer you can produce your own insulin, the better it is for the control of your sugar levels and long-term complications. Therefore we plan to monitor C-peptide measurements in new clinical studies where we trial new medicines to see if they can help preserve beta cell function.

C-peptide can be measured from a blood sample taken from a vein in your arm but the processing of the sample once it is collected is quite lengthy. However, at the University of Cambridge researchers have recently helped to develop a method to measure C-peptide from finger blood drops taken by pricking your finger (dried blood spots). We are not sure yet whether this new method is as accurate as the standard method but we aim to investigate this in the study.

Study Design
This is an observational study where researchers will find out if measuring C-peptide from dried blood spots is as accurate as taking a blood sample from your arm.

Eligibility for C-pepT1D
 Informed consent
 Children and young people aged 5 – 18 years with type 1 diabetes requiring insulin treatment
 Must join the study within 6 months from diagnosis

Exclusion from C-pepT1D
 Children and young people diagnosed with type 2 or monogenic diabetes and secondary diabetes
 Children and young people diagnosed with coeliac disease
 Children and young people taking oral steroids or immunosuppressive agents
 Females who are pregnant

Coordination Sponsorship and Funding
This C-pepT1D study will be coordinated from the University Department of Paediatrics at the University of Cambridge and is sponsored jointly by the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust. Funding is provided by the Wellcome Trust, Cambridge Biomedical Research Centre and Novo Nordisk.